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PACKAGE LEAFLET: INFORMATION FOR THE USER D03226

Pilocarpine Eye Drops 1%, 2% and 4% w/v 11. Repeat steps 5-10 above for your other eye With long term use it is possible that the lens of Pilocarpine Hydrochloride if you have been told to use Pilocarpine Eye your eye may change shape resulting in changes (Referred to as Pilocarpine Eye Drops in this leaflet) Drops in both eyes. to your vision. 12. Replace the outer cap on the bottle, Read all of this leaflet carefully before you start using this medicines because it contains trying not to touch the applicator tip with You may not know if you have some of the side important information for you. anything, including the eye or your fingers. effects. Your doctor will detect them during • Keep this leaflet. You may need to read it again. 13. Wash your hands. examinations. • If you have any further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it onto others. It may harm them, Always use this medicine exactly as described in Reporting of side effects even if their signs of illness are the same as yours. this leaflet or as your doctor has told you. Check Reporting suspected adverse reactions after • If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible with your doctor or pharmacist if you are not authorisation of the medicinal product is side effects not listed in this leaflet. See section 4. sure. important. It allows continued monitoring of the benefit/risk balance of the medicinal product. What is in this leaflet: • medicines used to make the pupil larger Your doctor will decide how much you need Healthcare professionals are asked to report and dry up the in your mouth, such as based on the severity of your condition and your any suspected adverse reactions via the Yellow and phenylephrine. response to treatment. Card Scheme Website: http://www.mhra.gov.uk/ 1. What Pilocarpine Eye Drops are and what are • medicines used to treat Parkinson’s disease, yellowcard. they used for drugs such as , 2. What you need to know before you use Adults (including the elderly) and . The usual dose is two drops three times daily. Pilocarpine Eye Drops • antidepressants including tricyclic 5. How to store Pilocarpine Eye 3. How to use Pilocarpine Eye Drops antidepressants (such as ) and Drops 4. Possible side effects monoamine oxidase inhibitors (MAOI’s), Use in children 5. How to store Pilocarpine Eye Drops a type of medicine used to treat severe Lowest available dose and concentration 6. Contents of the pack and other information should be used at the start of the treatment Keep this medicine out of the sight and reach of depression. children. • (medicines used to for children under 18 years of age. Your treat serious mental disorders) e.g. doctor might increase the dose up to the 1. What Pilocarpine Eye Drops are maximum recommended adult dosage of the Make sure the container is properly closed after . each use. Store Pilocarpine Eye Drops in their and what are they used for • medicines used to treat high blood pressure 2 % Pilocarpine eye drops depending on the response and tolerability. original container to protect from moisture and (adrenergic blockers) such as . away from direct light. Store below 25°C. Pilocarpine Hydrochloride belongs to a group of medicines called miotics, these medicines affect If you have any doubts about whether you If you use more Pilocarpine Eye Drops than Do not use Pilocarpine Eye Drops after the expiry muscles in the eye causing the pupil of the eye should use this medicine talk to your doctor you should date which is printed on the label. The expiry to get smaller. or pharmacist. If you are at all concerned that you have used or date refers to the last day of that month. been given too much of this medicine please tell Pilocarpine Eye Drops are used to treat certain Pilocarpine Eye Drops with food,drink and your doctor. Dispose of this medicine 28 days after opening. forms of (an increase in the pressure within the eye) and to reverse the effect of drugs You are advised not to drink alcohol during If you swallow any Pilocarpine Eye Drops Medicines should not be disposed of via waste that cause the pupil of the eye to get bigger. your treatment with Pilocarpine Eye Drops. Pilocarpine Eye Drops are for external use only. water or household waste. Ask your pharmacist If you have swallowed or you suspect someone how to dispose of medicines no longer required. 2. What you need to know before , breast-feeding and fertility else has swallowed any Pilocarpine Eye Drops, These measures will help to protect the you use Pilocarpine Eye Drops If you are pregnant or breast feeding, think contact your doctor or go to the accident and environment. you may be pregnant or are planning to have a emergency department of your local hospital at baby, ask your doctor for advice before taking once. Always take the container and this leaflet 6. Contents of the pack and other Do not use Pilocarpine Eye Drops if: this medicine. with you if possible, even if empty. • you are allergic (hypersensitive) to Pilocarpine information or any of the other ingredients in this If you forget to take Pilocarpine Eye Drops medicine, which are listed in section 6 of this Driving and using machines If you miss a dose of Pilocarpine Eye Drops, What Pilocarpine Eye Drops contain leaflet Pilocarpine Eye Drops can cause difficulty in use them as soon as you remember unless it The active substance is Pilocarpine • you are suffering from inflammation of the adapting to the dark. You should not drive or use machinery in poor light. The eye drops may is nearly time for the next dose, then carry on hydrochloride 1%, 2% or 4% w/v coloured part of the eye (acute iritis or anterior using it as before. Do not take a double dose to uveitis) also cause blurred vision. If this happens, you make up for one you have missed. The other ingredients are benzalkonium • you are suffering from eye disorders such should not drive or operate machinery until and purified water. as narrow angle glaucoma or secondary you can see clearly. glaucoma. If you stop using Pilocarpine Eye Drops • you are wearing soft contact lenses. Pilocarpine eye drops contains You should keep using Pilocarpine Eye Drops for What Pilocarpine Eye Drops look like and benzalkonium as long as your doctor has asked. Your treatment contents of the pack is helping your condition, even if you have not Pilocarpine Eye Drops are a clear, colourless and Warnings and precautions: This medicine contains benzalkonium chloride noticed a difference in how you feel. Should you sterile solution supplied in a plastic dropper Talk to your doctor or pharmacists before taking which may cause eye irritation and is known to discolour soft contact lenses. need to stop your treatment, your doctor will bottle. Each bottle contains 10ml of the solution. Pilocarpine eye drops if advise you how to do this. Soft contact lenses must not be worn during Marketing Authorisation Holder: • you are suffering from any heart problems. If you have any further questions on the use of treatment with Pilocarpine Eye Drops. Martindale Pharmaceuticals Ltd • you have . the medicine, ask your doctor or pharmacist. • you have Parkinson’s disease. T/a Martindale Pharma • you have problems in passing urine. Bampton Road • you have high blood pressure. 3. How to use Pilocarpine Eye 4. Possible side effects Harold Hill • you have a stomach ulcer. Drops Romford Essex RM3 8UG UK • you are pregnant or are breast-feeding. Like all medicines, this medicine can cause side Always use Pilocarpine Eye Drops exactly as effects, although not everyone gets them. Manufacturers: If you are unsure about how to use Pilocarpine your doctor has told you. Always complete a Martindale Pharmaceuticals Ltd Bampton Road Eye Drops talk to your doctor or pharmacist. course of treatment. Do not stop because you Harold Hill feel better. Common side effects (may affect 1 and 10 in Romford Essex RM3 8UG UK Children every 100 patients): Pilocarpine should be given at the lowest Pilocarpine Eye Drops are for external use only. • itching, smarting and a burning sensation around the eye Marketing Authorisation numbers: available dose at the start of the treatment for Pilocarpine Eye Drops 1% w/v PL 00156/0079 children under 18 years of age. • a red skin rash with itching (urticaria) Instructions for use • swelling, redness or soreness of the eyelid Pilocarpine Eye Drops 2% w/v PL 00156/0080 1. Before opening a new bottle of Pilocarpine • swelling of the front of the eye (conjunctiva) Pilocarpine Eye Drops 4% w/v PL 00156/0078 Eye tests Eye Drops, please check that the safety strip • temporarily blurred vision Your doctor may want to check your eyes before on the front of the bottle is unbroken. • temporary short sightedness This leaflet was last revised in: 04/2016 and during your therapy particularly if you have 2. Tear off the safety strip to break the seal. • difficulty in seeing in poor light had any eye disorders. If you have not had your 3. Wash your hands well before use. • enlargement of the veins in the eye eyes checked recently, tell your doctor. 4. Remove the outer cap. If you are putting • headache and brow ache (especially in young in the eye drops yourself, you should use a patients at the beginning of treatment) mirror. • bleeding within the front of the eye Other medicines and Pilocarpine 5. Tilt your head back and look up at the Please tell your doctor or pharmacist if you • detachment of the retina (the inner surface of ceiling. the eye) are taking or have recently taken any other 6. Pull the lower lid of the eye out to form a medicines, including medicines obtained small pocket between your eyelid and your without a prescription. eye. Rare may affect up to 1 in 1,000 people: 7. Hold the container between the thumb and • feeling sick (nausea) Some medicines can interfere with your middle finger of the other hand, turn the • being sick () treatment. Tell your doctor if you are taking any bottle upside down near to the eye, try not • diarrhoea of the following: to touch the eye with the nozzle. • increase in saliva 8. Apply enough pressure to the bottle to • increased flow of earst • antihistamines (medicines used to treat release one to two drops, as directed by • trembling or shaking ). your doctor. • wheezing and breathing difficulties • anticholinesterases, (such as ) 9. Blink your eye a few times. • change in blood pressure or changes in the which are medicines that affect the muscles 10. If you think that you have missed your eye, way your heart beats and are used to treat diseases like myasthenia then insert another drop. D03226 gravis. Continued overleaf

100mm Measurement Verification Bar

3226-C